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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05165485
Other study ID # 0180
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 7, 2022
Est. completion date November 20, 2023

Study information

Verified date December 2023
Source Theravance Biopharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.


Recruitment information / eligibility

Status Completed
Enrollment 404
Est. completion date November 20, 2023
Est. primary completion date November 13, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: 1. Participant is a male or female 40 years of age or older. 2. Participant is female and is nonpregnant and nonlactating. A woman of childbearing potential must have a documented negative urine pregnancy test at screening. Women are considered not to be of childbearing potential if they have had a total hysterectomy and/or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal. 3. During the study and for 30 days after receiving the last dose of study drug, women of childbearing potential and men capable of fathering children must agree to use highly effective birth control measures or agree to abstain from sexual intercourse. A highly effective method of birth control is defined as one that results in a low failure rate (i.e. <1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device [IUD] with documented failure rate of <1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with an additional barrier method. 4. Participant has a diagnosis of COPD, specifically, a post-ipratropium FEV1/FVC ratio <0.7. 5. Participant has a post ipratropium 30% = FEV1 < 50% of predicted normal (using National Health and Nutrition Examination Survey-predicted equations) and absolute FEV1 > 500 mL, or FEV1 <30% predicted normal and absolute FEV1 > 700 mL. 6. Participant has a PIFR <60 L/min as measured by an In-Check™ device with resistance set to DISKUS at Visit 1A (if not combined with Visit 1B) and < 55 L/min as measured by an In-Check™ device with resistance set to DISKUS at Visit 1B and Visit 2 prior to randomization. 7. Participant is capable of performing reproducible spirometry maneuvers (and plethysmography maneuvers for a subset of participants) as described by current American Thoracic Society (ATS) Guidelines. 8. Participant is an active or former smoker with a cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years. 9. Participant or legal guardian is willing and able to provide signed and dated informed consent to participate prior to initiation of any study related procedures. 10. Participant is willing and able to adhere to all study assessments/procedures. Care partner assistance is acceptable. 11. Participant is willing and able to adhere to all restrictions during their study participation as follows: - Use of recreational drugs - Medicinal marijuana - Excessive alcohol during the study period - Participation in another investigational drug study - Donation of =500 mL blood (or equivalent) 12. Participant (or care partner) based on the investigator's assessment is able to properly prepare and administer study medication administered from both nebulizer and HandiHaler® according to their respective Instructions for Use. Exclusion Criteria: 1. Participant has a concurrent disease or condition that, in the opinion of the investigator, would interfere with study participation or confound the evaluation of safety and tolerability of the study drug. 2. Participant has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics. 3. Participant suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention. 4. Participant has Moderate to Severe Hepatic impairment (Child-Pugh B or C) or Severe Renal Insufficiency (i.e. a glomerular filtration rate <30 mL/min/1.72m2). 5. Participant has been hospitalized for COPD or pneumonia within 8 weeks prior to Visit 1. 6. Participant is receiving a LABA or LABA/inhaled corticosteroid (ICS; either QD or BID) at a dose that has been stable for = 30 days prior to screening. 7. Participant has used systemic corticosteroids within 8 weeks of Visit 1. 8. Participant has used antibiotics for respiratory tract infections within 8 weeks of Visit 1, or is using antibiotics prophylactically. 9. Participant received COVID-19 vaccine within 2 weeks prior to Visit 1.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Revefenacin
Revefenacin DoseA
Tiotropium
Tiotropium DoseB
Revefenacin Placebo
Placebo for Revefenacin administered with Tiotropium
Tiotropium Placebo
Placebo for Tiotropium administered with Revefenacin

Locations

Country Name City State
United States Theravance Biopharma Investigational Site Anderson South Carolina
United States Theravance Biopharma Investigational Site Charlotte North Carolina
United States Theravance Biopharma Investigational Site Cincinnati Ohio
United States Theravance Biopharma Investigational Site Clearwater Florida
United States Theravance Biopharma Investigational Site Clearwater Florida
United States Theravance Biopharma Investigational Site Columbia South Carolina
United States Theravance Biopharma Investigational Site Columbus Ohio
United States Theravance Biopharma Investigational Site Farmington Hills Michigan
United States Theravance Biopharma Investigational Site Franklin Tennessee
United States Theravance Biopharma Investigational Site Gaffney South Carolina
United States Theravance Biopharma Investigational Site Grants Pass Oregon
United States Theravance Biopharma Investigational Site Greenville South Carolina
United States Theravance Biopharma Investigational Site Jasper Alabama
United States Theravance Biopharma Investigational Site Knoxville Tennessee
United States Theravance Biopharma Investigational Site Las Vegas Nevada
United States Theravance Biopharma Investigational Site Leesburg Florida
United States Theravance Biopharma Investigational Site Lexington South Carolina
United States Theravance Biopharma Investigational Site Medford Oregon
United States Theravance Biopharma Investigational Site Miami Florida
United States Theravance Biopharma Investigational Site Miami Florida
United States Theravance Biopharma Investigational Site Monroe North Carolina
United States Theravance Biopharma Investigational Site North Charleston South Carolina
United States Theravance Biopharma Investigational Site North Dartmouth Massachusetts
United States Theravance Biopharma Investigational Site Orlando Florida
United States Theravance Biopharma Investigational Site Ormond Beach Florida
United States Theravance Biopharma Phoenix Arizona
United States Theravance Biopharma Investigational Site Portland Oregon
United States Theravance Biopharma Investigational Site Raleigh North Carolina
United States Theravance Biopharma Investigational Site Rock Hill South Carolina
United States Theravance Biopharma Investigational Site Saint Charles Missouri
United States Theravance Biopharma Investigational Site San Antonio Texas
United States Theravance Biopharma Investigational Site Sarasota Florida
United States Theravance Biopharma Investigational Site Sherman Texas
United States Theravance Biopharma Investigational Site Spartanburg South Carolina
United States Theravance Biopharma Investigational Site #2 Spartanburg South Carolina
United States Theravance Biopharma Investigational Site Tampa Florida
United States Theravance Biopharma Investigational Site Union South Carolina
United States Theravance Biopharma Investigational Site Valparaiso Indiana
United States Theravance Biopharma Investigational Site Winter Park Florida

Sponsors (2)

Lead Sponsor Collaborator
Theravance Biopharma Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary FEV1 Change from baseline in trough FEV1 Day 85 following 84 days of dosing
Secondary OTE on FEV1 Trough Overall treatment effect (OTE) on FEV1 Day 30 through Day 85
Secondary FEV1 Change from baseline in Trough FEV1 on Day 30 Day 30
Secondary FEV1 Change from baseline in Trough FEV1 on Day 60 Day 60
Secondary FVC Change from baseline in Trough FVC Day 85
Secondary 80-mL improvement in trough FEV1 Percentage of participants who achieve at least an 80-mL improvement in trough FEV1 Day 85
Secondary Time to first CompEx Composite endpoint for exacerbations of COPD event Baseline through Day 85
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